Vacuum extraction monitoring

ABSTRACT

The present invention aids a person who is assisting with fetal extraction by monitoring and recording the pressure inside a vacuum device. The invention includes a suction device that is enabled for vacuum attachment to a fetus, a pump that is capable of producing a vacuum pressure, and tubing that fluidly couples the suction device to the pump. In another embodiment, the invention is embodied as a method that includes the acts of attaching a suction device to a fetus, detecting the vacuum pressure, and recording the vacuum pressure.

RELATED APPLICATIONS

[0001] The present invention is related to co-filed and co-pending U.S.patent application No. TBA, entitled Vacuum Extraction Monitor withAttachment For Hand Pump by Dr. Victor Vines, attorney docket number108747.00003, and co-filed and co-pending U.S. patent application No.TBA, entitled Vacuum Extraction Monitor for Electric Pump, by Dr VictorVines, attorney docket number 108747.00004. All of which were filed onNov. 30, 2000.

TECHNICAL FIELD

[0002] The invention relates to childbirth, and more specifically, theinvention relates to vacuum extraction deliveries. More particularlystill, the invention relates to systems, devices, and methods formonitoring vacuum extraction deliveries.

[0003] Statement of a Problem Addressed by this Invention

[0004] When operative vaginal deliveries are necessary, there arepresently two options—forceps extraction, or vacuum extraction. Vacuumextraction in labor/delivery suites has become a well-accepted andcommonly performed form of vaginal delivery because it may be lesshazardous to the mother and fetus than forceps extraction. However,there is the potential for harm to the fetus from prolonged suctionapplication to the fetal head. In addition, there are guidelinesprolonged suction application to the fetal head. In addition, there areguidelines governing the amount of vacuum pressure that should beapplied to the fetal head, as well as guidelines regarding the durationof time that the vacuum pressure is applied to the fetal head duringvacuum extraction (these guidelines are printed by the manufacturers ofvacuum devices, and are also available in medical literature).

[0005] Exemplary effects of vacuum extraction on an infant duringdelivery include: fetal hypoxia, retinal hemorrhage, chignon-scalpmarking and abrasion, cephalhematoma and subcutaneous hematoma, neonataljaundice, intra-cranial hemorrhage, shoulder dystocia, and subgalealhemorrhage. Subgaleal hematoma is a particularly dangerous condition.Subgaleal hematoma is formed when bleeding occurs into the potentialbeneath the aponeurosis of an infant's scalp. It may be a lifethreatening condition for a newborn baby, and is often considered themost serious complication associated with the vacuum extraction. Onedanger associated with subgaleal hematoma arises because thesubaponeurotic space stretches over the whole part of the cranial vaultof the infant, and a large proportion of the baby's blood volume canaccumulate in this space (typically, from damage to the emissary veins).Although subgaleal hematoma may occur after forceps and naturaldeliveries, the incidents of subgaleal hematoma is increasedconsiderably in vacuum extractions since the introduction of the vacuumdevice pulls the aponeurosis from the cranium and may injure theunderlying veins. Furthermore, because hemorrhaging into the subgalealspace may occur slowly, and for several hours following delivery,bleeding into the subgaleal space may be difficult to initially detect.

[0006] Accordingly, there are occasions when a fetus does poorly duringand after vacuum extraction. Often, a legal claim is made against adoctor, hospital, nurses, and others associated with the delivery,alleging that the guidelines regarding the use of the vacuum device werenot followed.

[0007] Other complications involved with using vacuum devices includeattention being diverted away from the delivery process itself whenattention is given to the vacuum pressure being applied to the fetalhead. Furthermore, large amounts of activity by different personnel whoparticipate in the delivery may create confusion and chaos in which themonitoring of a vacuum pressure in the vacuum device goes undocumented.The present invention provides a solution that overcomes these and otherdisadvantages associated with the prior art.

[0008] Selected Overview OF Selected Embodiments

[0009] The present invention provides technical advantages as systems,devices, and methods for aiding a person who is assisting with fetalextraction. The invention is attachable to a vacuum device, and mayincorporate a vacuum device. Accordingly, the pressure inside the vacuumdevice is monitored and recorded by a recording device. Thus, theinvention allows the measurement of, and provides for the recording ofthe amount of pressure and the duration of pressure applied to a fetus'shead during vacuum extraction. Furthermore, the invention lowerslitigation costs because a permanent record of vacuum pressures appliedduring delivery is created.

[0010] In another embodiment, the invention is a vacuum device foraiding a person who is assisting with fetal extraction. The inventionincludes a suction device that is enabled for vacuum attachment to afetus, a pump that is capable of producing a vacuum pressure, and tubingthat fluidly couples the suction device to the pump.

[0011] In another embodiment, the invention is a method of aiding aperson who is assisting with fetal extraction. The method includesattaching a suction device to a fetus, preferably at a vacuum pressure,detecting the vacuum pressure, and recording the vacuum pressure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Various aspects of the invention, as well as an embodiment, arebetter understood by reference to the following EXEMPLARY EMBODIMENT OFA BEST MODE. To better understand the invention, the EXEMPLARYEMBODIMENT OF A BEST MODE should be read in conjunction with thedrawings in which:

[0013]FIG. 1 provides a block diagram of a vacuum device, illustratingsystems incorporated by the invention;

[0014]FIG. 2 provides a more detailed block schematic of a vacuumdevice;

[0015]FIG. 3 provides a flowchart of a recording algorithm whichillustrates one embodiment of the invention;

[0016]FIG. 4 illustrates a block flow diagram of a vacuum devicealgorithm that implements one embodiment of the invention;

[0017]FIG. 5 provides a block diagram of an adapter assembly whichprovides existing vacuum devices the features of the invention, and isaccordingly another embodiment of the invention;

[0018]FIG. 6 illustrates a pump attachable device capable of attachmentto an electrical pump;

[0019]FIG. 7 as a tube attachable device; and

[0020]FIG. 8 illustrates a pump attachable device configured to attachto a hand pump, such as a KIWI hand pump.

AN EXEMPLARY EMBODIMENT OF A BEST MODE

[0021] The invention allows physicians to measure and record the amountof pressure and the duration of pressure applied to a fetus' head duringvacuum extraction, and the invention lowers litigation costs because apermanent record of vacuum pressures applied during delivery is created.Accordingly, the invention provides systems, devices, and methods foraiding a person who is assisting with fetal extraction. The invention isattachable to a vacuum device, and may incorporate a vacuum device.Furthermore, the pressure inside the vacuum device is monitored andrecorded by a recording device.

[0022] Preferably, the invention provides at least the features ofmonitoring and recording pressures in a suction device used forvacuum-based fetal extraction. Accordingly, FIG. 1 provides a blockdiagram of a vacuum device 100, illustrating systems incorporated by theinvention. A pump 110 which could be a manually activated hand pump, anelectric pump, or any other type of air pump, is fluidly coupled to asuction device 120. The suction device 120 is attachable to a fetus,being preferably attachable to fetal head. The suction device 120 ispreferably a cup, such as a SILC, a SILASPIC, a SOFT-CUP, or a MALMSTROMcup, for example. Fluid coupling between the suction device 120 and thepump 110 may be accomplished by a tube 112, and is preferably a plastictube.

[0023] A recording device 130, which may be a monitor, an enhancedmonitor, or a custom-developed device for example, provides a user theability to monitor air pressures and record air pressures. Accordingly,air pressures may be measured in the monitor 130, or in the tube 112, orin the pump 110. Furthermore, in FIG. 1, a cable 116 couples the tube112 to the monitor 130. Accordingly, in this embodiment, an air pressureis detected in the tube 112 and converted into information by a devicesuch as a transducer. Next, the detected pressure is passed asinformation along the cable 116 to the monitor 130.

[0024] With an initial understanding of the vacuum device 100, one maygain a better understanding of the invention by referring to a moredetailed block schematic. Accordingly, FIG. 2 provides a more detailedblock schematic of a vacuum device 200. The vacuum device 200 has a pump110 in fluid communication with the suction device 120 through a tubing112. The tubing 112, although not illustrated, may contain therein awire for coupling the pump 110 to the suction device 120 (to provide adevice which may support traction tension between the pump 110 and thesuction device 120). A coupling 114 is shown dividing the tubing 112.However, it should be understood that the coupling 114 need not beintrusive of the tubing 112, and could be embodied as a cap/tap, forexample. In any event, the coupling is enabled to detect the pressure inthe tubing (whether the pressure is actually detected in the tubing 112,the suction device 120, or the pump 110). Preferably, the coupling 114is a plastic tube with a transducer therein. Although not shown in FIG.2, a transducer in the coupling detects a pressure, and then produces amechanical or electrical signal based on the pressure detected. or othertransportable signal based on the detective pressure such as a wirelessradio frequency communication).

[0025] The cable 116 provides a commutative connection between thecoupling 114 and a pressure gauge 132 located in the recording device130. Of course, although the pressure gauge 132 is illustrated as beinglocated in the recording device 130, the pressure gauge 132 could infact be located in the coupling 114, or along the cable 116. Thus, thepressure gauge 132 functions as a mechanical or electrical signalreceiver which translates a mechanical signal, or electrical signal, ora wireless signal into data that is associated with a pressure.

[0026] A processor 140 was coupled to the pressure gauge 132, andprovides a means for processing data from the pressure gauge 132 andassociating that data with various tables, algorithms, and otherinformation. Furthermore, processor 140 may drive other systems such asa display 136, a printing device 138, warning system 144, or a safetysystem 142, or send information to a recording device 134. Preferably,the processor is a digital signal processor (DSP), a Pentium processor,or a Strong Arm processor, for example. The processor 140 retrievesvarious tables, algorithms, and other information from the recordingdevice 134, that preferably stores an electronic record. Preferably, therecording device 134 is embodied as memory, such as RAM, ROM, orremovable memory such as Flash RAM, a Memory Stick, or a CD ROM.

[0027] The display 136 provides real time information, such as pressuresover time, dangerous conditions detected (or other information) topersons assisting with the extraction of the fetus. Preferably, thedisplay 136 is a cathode ray video screen, or a plasma screen.

[0028] The printing device 138 provides the ability to print numbers orgraphs indicating a pressure over time, progressive pressures detectedover time. Preferably, the printing device 138 generates these prints onpaper. Furthermore, although illustrated as being integrated into therecording device 130, it should be understood that the printing device138 may be located externally from the recording device 130.

[0029] The safety system 142 causes the implementation of a safetypressure release valve preferably located on the pump 110. Whentriggered, the safety system 142 may release some of the pressure, orall of the pressure thus returning the pressure inside the tubing 112 tothe local atmospheric pressure (or room pressure). The safety system 142may be embodied as software algorithm for execution in memory, or asmechanical device.

[0030] The warning system 144 is for producing a warning when apredetermined pressure or pressures are detected. Typically, thepredetermined pressure will be a vacuum pressure which is lower than apredetermined vacuum pressure, such as 0.2 kgms/cm²-0.8 kgms/cm²,depending on the stage of delivery. The warning may be embodied as alight, a sound, or a voice, for example. A light may flash at differentrates, or present different colors, or present different intensities aspressure changes in the tube. Similarly, a sound may change in tone asdifferent pressures are detected, or a voice may verbally indicate apressure or a warning condition. Furthermore, the warning system may beused to trigger and provide information to the safety system 142.

[0031] A better understanding of the invention may be achieved byexamining the operation of the invention. FIG. 3 provides a flowchart ofa recording algorithm 300. First, in a record pressure act 310, therecording algorithm 300 records a pressure which exists in a vacuumdevice. Then, in a store recorded pressure act 320, the recordingalgorithm 300 creates a permanent record of the pressure which wasrecorded in the record pressure act 310.

[0032] An even better understanding of the invention may be realized byexamining the processes flow of a vacuum device embodied according tothe invention. Accordingly, FIG. 4 illustrates a block flow diagram of avacuum device algorithm 400 that implements one embodiment of theinvention. The vacuum device algorithm 400 comprises a pump algorithm402 for illustrating acts performed with a vacuum device pump, and amonitor algorithm 405 illustrating acts associated with a recordingdevice. The vacuum device algorithm 400 begins in a pump algorithm 402.

[0033] The pump algorithm 402 is initiated in an engage monitor act 410.The engage monitor act may include attaching a cable between a vacuumpump and a recording device, and then turning on the recording device.After the engage monitor act 410, the pump algorithm 402 proceeds to anapply suction device act 415 in which a suction device is attached to afetus, and preferably a fetal head. It should be noted that in the applysuction device act 415, if a disposable MITYVAC is being used in theprocedure, adapters should be attached to suction tubing of the vacuumdevice and the disposable MITYVAC assembly. After the suction device isapplied to the fetus, the apply suction device act 415 proceeds bycalibrating, or zeroing, the monitor so that the pressure detected priorto applying a vacuum to the fetus is recognized as being the localatmospheric pressure.

[0034] Following the apply suction device act 415, the pump algorithm402 proceeds to an initiate vacuum act 420. In the initiate vacuum act420 a vacuum pressure is created in the vacuum device by manuallyactuating a manual pump, or by engaging the vacuum switch or trigger inan electric pump. The next act in the pump algorithm 402 change, thevacuum pressure (which is initiated in response to a command to changethe pressure in the vacuum device). This is accomplished in analtervacuum pressure act 425, and is typically employed as a result of aresponse received from the monitor algorithm 405. Of course, alteringthe vacuum pressure may not be necessary during a vacuum extractionprocedure, and thus the alter vacuum pressure act 425 should especiallybe viewed as an optional act for the present embodiment (although theonly needed acts are explicitly articulated in the claims).

[0035] Next, a disengage vacuum act 430 is performed when the pressurein the vacuum device is returned to at least local atmospheric pressure.Furthermore, the pressure may be raised to a pressure greater than localatmospheric pressure to encourage the suction device to separate fromthe fetus. Then, the vacuum device algorithm 400 and pump algorithm 402end together in a remove suction device act 435, in which the suctiondevice is removed from the fetus. Furthermore, in the remove suctiondevice act 435 the recording device may be disengaged, and the record ofthe pressures detected during the vacuum device algorithm 400 may bestored in a permanent medical record, which may be a physical paperrecord and/or an electronic record.

[0036] The monitor algorithm 405 initiates in a detect pressure act 450,which begins in response to the initialization of the recording devicein the engage monitor act 410. In the detect pressure act 450 a pressurein the vacuum device is detected, which will typically be between a room(or atmospheric) pressure and vacuum pressure (meaning a pressure lowerthan the local atmospheric pressures). Next, the vacuum device algorithm400 continues to a record pressure act 455. In the record pressure act455 the pressure detected in the detect pressure act 450 isautomatically recorded (or stored), preferably by an electronic means(such as a memory) or by a paper means. Furthermore, the record pressureact 455 may include the displaying of the recorded pressure on a monitoror other display.

[0037] The recorded pressures are monitored and processed in a processrecorded pressure act 460. The process recorded pressure act 460evaluates the detected pressure in a warning system, and may direct thedisplaying or printing of additional information in response to thewarning system. [The process-recorded pressure 460 may include a sub-actof displaying the processed information on the display device, such as amonitor.] Likewise, if the process is recorded at 460 determines if thedetected pressure exceeds a predetermined pressure, the process recordedpressure act 460 may direct a pressure change, such as a lower pressure,or an immediate return to local atmospheric pressure, in a directpressure change act 465. The direct pressure change act 465 produces theelectrical or mechanical signals needed to implement the alter-vacuumpressure act 425.

[0038] The intention provide the ability to accurately measure, record,and trace pressure event that transpire in a vacuum device during vacuumextraction. Accordingly, the invention assist physicians, hospitals, andother delivery personnel in the defense of accusation that properguidelines were not followed during the vacuum extraction. Furthermore,those who suffer from improper vacuum extraction also have access to apermanent medical record which should facilitate mediated settlements,and avoid the costs of lengthy discovery and emotionally scaringlitigation. Also, because data will be collected with each vacuumextraction, the guidelines for the conduct of a vacuum extraction may bechanged and improved to more accurately be able to predict safeguidelines for a vacuum extraction delivery.

[0039] It will sometimes be advantageous to provide existing vacuumdevices the ability to access the advantages provided by the invention.FIG. 5 provides a block diagram of an adapter assembly 500 whichprovides existing vacuum devices access to advantages of the invention,and is accordingly another embodiment of the invention. The adapterassembly 500 comprises a pump 510 fluidly coupled to a suction device520 by a tubing 525. A display device 530 is connected to the pump 510.Preferably, the display device 530 is coupled to the pump 510 via anadapter to the pump 510. Better understanding of the adapter assembly500 may be achieved by examining specific embodiment.

[0040]FIG. 6 illustrates a pump attachable device 600 capable ofattachment to an electrical pump 655. The pump attachable device 600 hasan adapter 610, such as the threaded fittings illustrated in FIG. 6.Furthermore, the pump attachable device 600 has a pressure transducer620 which detects a pressure and converts the detected pressure to amechanical or electrical signal capable of being transferred to amonitor (not shown) via a cable 630. The cable 630 includes a plug 635capable of attachment to a monitor or other recording device.

[0041] Also, illustrated in FIG. 6 is a pump system 650 having a pumpattachable device attached thereto. The pump system 650 includes anelectric pump 655 such as a MITYVAC, or disposable MITYVAC, for example.The electric pump655 has a front end 665 which has a cavity forsupporting other devices and for transporting the pressures, includingthe vacuum pressure, created by the electric pump 655.

[0042] The front end 665 has thereon a pressure gauge receiver 660.Typically, the pressure gauge receiver 660 accepts a pressure gauge thatmechanically detects a pressure which is then displayed for thoseperforming the vacuum procedures. In operation of one embodiment of theinvention, the pressure gauge is removed from the electric pump,typically by unscrewing the pressure gauge, and the pump attachabledevice 600 is then inserted into the pressure gauge receiver 660. Alsoprovided by the front end 665 is a pressure release valve 670. Thepressure release valve 670 allows the inflow of air into the front end,and particularly into the cavity of the front end, in order to increasethe pressure in the vacuum device.

[0043] Another embodiment of the invention is illustrated in FIG. 7 as atube attachable device 700. The tube attachable device 700 includes afirst end 705, and a second end 707. The first end 705 is preferablyconfigured to either attach to a plastic tube section, or a suctiondevice. The second end 707 is preferably configured to attach to a tube,or a front end such as the front end 765 that is adapted to receive thesecond end 707. The tube attachable device 700 includes tubing 740,which is preferably plastic tubing.

[0044] The tubing 740 includes a pressure gauge receiver 760.Accordingly, a transducer/pressure gauge 720 is inserted into the tubing740 and secured in the tubing by an adapter 710. Furthermore, pressuresdetected by the pressure transducer 720 are converted into a data signalthat is sent to a recording device along a cable 730. The cable 730 alsoincludes a plug 735 which is connectable to the recording device monitor780, or to a second plug 737. The plug 737 couples an extension cord 738to a second plug 739. The second plug 739 is also attachable to therecording device 780 at a plug socket 788.

[0045] The vacuum device illustrated in FIG. 7 includes a pump 755,which provides a disposable MITYVAC, and a pressure gauge 760 which isfitted into the front end 765. Thus, the vacuum device provides aphysician the advantage of having a mechanical visual display providedby the gauge 760 (thus requiring little change by those who are accustomto viewing the mechanical gate 760), as well as providing mechanical andelectric displays and printouts of the recorded pressures while therecording device 780.

[0046] The recording device 780 may produce a printed-paper record 782,as well as a visual display 784. Of course, the printed-paper record 782or the visual display 784 may print or display numbers, graphicalrepresentation or other indicia of the pressures being detected in thevacuum device. Furthermore, the recording device 780 provides a warningdevice 786 which could produce a light, sound, or a vocalized recordingof a warning to those assisting with the fetal extraction.

[0047]FIG. 8 illustrates a pump attachable device 800 configured toattach to a hand pump 855, such as a KIWI hand pump. The pump attachabledevice 800 includes an adapter 810, such as threading, gaskets, or otherattachments capable of forming a fluid-tight seal, a pressure-recordingdevice 820, such as a transducer, and a cable 830 for communicating adetected pressure to a recording device via a plug 835. The hand pump855 includes a handle 857 which maintains a vacuum cavity 865 therein.The vacuum cavity 865 is fluidly connected to a hose 870 and a suctiondevice 872. The handle 857 also includes a pressure gauge receiver 860.In an unmodified hand pump, the pressure gauge receive 860 accepts amechanical pressure gauge that mechanically indicate a detected pressurein the vacuum cavity 865. In the vacuum device according to the presentembodiment of the invention, the pump attachable device 800 is securedinto the handle 857 of the hand pump 855 via the pressure gauge 860.

[0048] Though the invention has been described with respect to aspecific preferred embodiment, many variations and modifications willbecome apparent to those skilled in the art upon reading the presentapplication. It is therefore the intention that the appended claims beinterpreted as broadly as possible in view of the prior art to includeall such variations and modifications.

I claim:
 1. A vacuum device for aiding a person who is assisting withfetal extraction, comprising: a suction device that is enabled forvacuum attachment to a fetus; a pump that is capable of producing avacuum pressure; and a tubing that fluidly couples the suction device tothe pump.
 2. The vacuum device of claim 1 further comprising a recordingdevice coupled to the vacuum device, the recording device for creating apermanent record of the vacuum pressure.
 3. The vacuum device of claim 2further comprising a transducer coupled to the vacuum device [attachedto the recording device and] such that the transducer is capable ofdetecting a pressure in the vacuum device.
 4. The vacuum device of claim3 wherein the transducer generates a mechanical indicia of the pressure.5. The vacuum device of claim 3 wherein the transducer generates anelectrical signal the electrical signal being indicative of thepressure.
 6. The recording device of claim 2 wherein the recordingdevice is capable of producing a paper record.
 7. The recording deviceof claim 2 wherein the recording device produces an electronic record.8. The vacuum device of claim 1 wherein the suction device is attachableto the head of a fetus.
 9. The vacuum device of claim 1 wherein the pumpis a hand powered pump.
 10. The vacuum device of claim 1 wherein thepump is an electrically powered pump.
 11. The vacuum device of claim 1wherein the tubing comprises a plastic tube portion.
 12. The vacuumdevice of claim 1 further comprising a wire that couples the suctiondevice to the pump.
 13. The vacuum device of claim 2 further comprisinga warning device coupled to the recording device, the warning devicebeing capable of producing a warning when a predetermined pressure isdetected in the vacuum device.
 14. The vacuum device of claim 13 whereinthe warning is a sound.
 15. The vacuum device of claim 13 wherein thewarning is a light.
 16. The vacuum device of claim 13 wherein thepredetermined pressure is 0.2 kgms/cm².
 17. A method of aiding a personwho is assisting with fetal extraction, comprising: attaching a suctiondevice to a fetus, placing the vacuum device on a fetus and then byinducing a vacuum pressure in the suction device; detecting the vacuumpressure; and recording the vacuum pressure.
 18. A method of claim 17further comprising the act of changing the vacuum pressure in responseto the detected vacuum pressure.
 19. A method of claim 17 whereinrecording is a accomplished mechanically.
 20. The method of claim 17wherein recording is accomplished electronically.
 21. The method ofclaim 17 further comprising the act of displaying at least the vacuumpressure.